In the 3rd part of this series, we address how to balance empowering a design team to create a medical device that provides safe and effective therapy or diagnostic, while still ensuring adequate controls to achieve the standard and regulatory compliance and protect patients from harm.
How do we empower designers within their current creative process? Tools are continually being adapted and improved, so for many situations, there may be a different “right tool” for the job depending upon circumstances. As a specific example, traceability can be done using a text document, a spreadsheet, or a more sophistical tool, e.g., JAMA, but it is crucial that the proper tool is selected at the right time to achieve the desired result. We also need to adapt as new tools come into the industry, and the QMS should not over-burden these transitions. A quality manager must have the humility to admit when he or she may not know the best method to accomplish a goal and learn to lean on the team’s knowledge. While QMS principles are always enforced, the mechanics of execution should remain flexible wherever possible.
Empowerment during the design stage enables our engineers to keep re-evaluating, simplifying, and reducing overall risk, in order to achieve the safest, most effective design. It is imperative we place a high amount of effort into this iterative process before design completion and production begins.
Control becomes more critical as we move toward the manufacturing side of the product realization process. In general, manufacturing needs more filters and allows less variability than the design process. There are many reasons for this, including a need for production efficiency and the speed of manufacturing. But a more direct goal is that filters and reduction in variability are testing tools correctly used to ensure product conformance to specification.
Once a company confirms that its design is safe and effective, the production process needs to be able to reproduce that design without deterring from the original blueprint. If you view the manufacturing process as a kitchen, the recipe is the Device Master Record (DMR), the ingredients are the Bill of Materials (BOM and SBOM, if required), and the manufacturing staff is the chefs. Chefs do not need to know all of the nuances (Device History File – DHF) that went into creating the recipe, only how to follow the method to create the desired result.
Manufacturing can also be considered one of the last lines of defense for patient safety. QMS protection becomes all the more critical when we are increasing the quantity of production (magnifying the potential breadth of impact of a safety or security event) or completing repetitive activities within manufacturing. It is critical that all process improvements have been appropriately validated before greenlighting full production. Reducing variability at the manufacturing stage provides the double benefit of patient protection and improved yield for cost savings (again, consistent with our passion for reducing healthcare costs).
Overall, we want to emphasize how important it is to dedicate the time and energy to ensuring that proper control is applied in the right places. Problems (both practical and cultural) can arise when rigorous manufacturing controls are uniformly applied throughout an organization. A crucial part of developing an effective lean QMS is understanding how applying controls will benefit the patient or end user. During design, controls should ensure principles are satisfied while allowing optimization of methods. During production, controls should likewise ensure policies are met, but also methods where control and invariability are necessary. It is not about how much control is applied overall, but rather where and how it is used to maximize the patient benefit from each control to result in timely and cost-effective delivery of a safe and effective device.
In our next post, we will explore the difference between a Standards-centric QMS and a Product-centric QMS. If you’d rather not wait, click here to download our QMS white paper.
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